The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion criteria

• Male or female patients aged 45-80 years;
• Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC<0.7, salbutamol reversibility <12%, supportive smoking history
• If female of childbearing potential, have a negative serum pregnancy test at screening and use a medically acceptable form of contraception starting at screening and continuing throughout the study (defined as an oral contraceptive, or barrier method combined with a spermicide)
• Able to attend for regular clinic appointments
• In opinion of investigator, the patient will be able to comply with the requirements of the protocol
• Provide written informed consent.

Exclusion criteria

• Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate
• Clinically significant liver function abnormality; alcohol excess
• Hypercholesterolaemia > or equal to 6.5mmol/L
• Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
• Any condition judged by investigator that would cause the study to be detrimental to patient.
• Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; known alpha 1 antitrypsin deficiency; malignancy; documented history of ischaemic heart disease (IHD); cor pulmonale or known congestive heart failure; patients planning to undergo elective surgery during the study period.
• Exacerbation in the last 4 weeks.
• Significant hypoxia (PaO2 <7.3kPa)
• Known lactose intolerance.
• Therapies: oral prednisolone for more than 1 week in the last 6 months; disease modifying drugs (Gold/ sulphasalazine etc); weight losing drugs; concomitant use of warfarin, cyclosporine; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone). Use of any investigational drug within four weeks of the baseline visit.